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A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability

Information source: KK Women's and Children's Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypotension

Intervention: vasopressor delivery automated system w/ (Device); phenylephrine (Drug); ephedrine (Drug); manual vasopressor delivery (Device)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: KK Women's and Children's Hospital

Official(s) and/or principal investigator(s):
Ban L Sng, FANZCA, Principal Investigator, Affiliation: KK Women's and Children's Hospital

Overall contact:
Ban L Sng, FANZCA, Phone: +6563941081, Email: sng.ban.leong@kkh.com.sg

Summary

Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step algorithm.

Clinical Details

Official title: A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Hypotension

Secondary outcome:

Hypertension

Nausea and vomiting

Detailed description: Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. We developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using Nexfin cardiac output monitor with a two-step algorithm. The system delivered phenylephrine 25 mcg or ephedrine 2 mg (if heart rate<60 beats. min-1) every 30 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 50 mcg or ephedrine 4 mg (if heart rate<60 beats. min-1) every 30 seconds when systolic blood pressure was <90% of baseline. A randomised controlled trial will be done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 50mcg or ephedrine 4mg (if heart rate<60 beats. min-1) every 60 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 100mcg or ephedrine 8mg (if heart rate<60 beats. min-1) every 60 seconds when systolic blood pressure was <90% of baseline.

Eligibility

Minimum age: 21 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- age 21-45 years old,

- weight 40-90 kg,

- height 145-170 cm

Exclusion Criteria:

- contraindications to spinal anaesthesia,

- allergy to drugs used in the study, and

- those with uncontrolled medical conditions such as hypertension, diabetes mellitus,

and cardiovascular disease

Locations and Contacts

Ban L Sng, FANZCA, Phone: +6563941081, Email: sng.ban.leong@kkh.com.sg

KK Women's and Children's Hospital, Singapore 229899, Singapore; Recruiting
Ban L Sng, FANZCA, Phone: +6563941081, Email: sng.ban.leong@kkh.com.sg
Alex T Sia, MMED, Phone: +6563941081, Email: Alex.Sia.TH@kkh.com.sg
Additional Information

Starting date: May 2013
Last updated: October 28, 2014

Page last updated: August 20, 2015

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